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WO2005112801A2 - Méthode pour l’implantation d’un cathéter médical par voie percutanée et assemblage de l’implantation d’un cathéter médical - Google Patents

Méthode pour l’implantation d’un cathéter médical par voie percutanée et assemblage de l’implantation d’un cathéter médical Download PDF

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Publication number
WO2005112801A2
WO2005112801A2 PCT/US2005/017496 US2005017496W WO2005112801A2 WO 2005112801 A2 WO2005112801 A2 WO 2005112801A2 US 2005017496 W US2005017496 W US 2005017496W WO 2005112801 A2 WO2005112801 A2 WO 2005112801A2
Authority
WO
WIPO (PCT)
Prior art keywords
medical catheter
distal end
bolster
sheath
assembly
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2005/017496
Other languages
English (en)
Other versions
WO2005112801A3 (fr
Inventor
Patrice A. Weststrate
Boyd A. Colvin
Changqing Li
Mark L. Adams
Donald C. Hovey
Laurence D. Brenner
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Boston Scientific Ltd Barbados
Boston Scientific Scimed Inc
Original Assignee
Boston Scientific Ltd Barbados
Scimed Life Systems Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Boston Scientific Ltd Barbados, Scimed Life Systems Inc filed Critical Boston Scientific Ltd Barbados
Priority to EP05750796A priority Critical patent/EP1758510A2/fr
Priority to JP2007513486A priority patent/JP4805257B2/ja
Publication of WO2005112801A2 publication Critical patent/WO2005112801A2/fr
Publication of WO2005112801A3 publication Critical patent/WO2005112801A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3415—Trocars; Puncturing needles for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0015—Gastrostomy feeding-tubes
    • A61J15/0023—Gastrostomy feeding-tubes inserted by using a sheath
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0026—Parts, details or accessories for feeding-tubes
    • A61J15/003—Means for fixing the tube inside the body, e.g. balloons, retaining means
    • A61J15/0034—Retainers adjacent to a body opening to prevent that the tube slips through, e.g. bolsters
    • A61J15/0038—Retainers adjacent to a body opening to prevent that the tube slips through, e.g. bolsters expandable, e.g. umbrella type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2200/00—General characteristics or adaptations
    • A61J2200/60—General characteristics or adaptations biodegradable

Definitions

  • the present invention relates generally to medical catheters and relates more particularly to a method for percutaneously implanting a medical catheter, such as a gastrostomy feeding tube, and to a medical catheter implanting assembly.
  • a medical catheter such as a gastrostomy feeding tube
  • a medical catheter implanting assembly Certain patients are unable to take food and/or medications transorally due to an inability to swallow. Such an inability to swallow may be due to a variety of reasons, such as esophageal cancer, neurological impairment and the like.
  • the intravenous administration of food and/or medications to such patients may be a viable short-term approach, it is not well-suited for the long-term.
  • gastrostomy i.e., the creation of a feeding tract or stoma between the stomach and the upper abdominal wall. Feeding is then typically performed by administering food through a catheter or feeding tube that has been inserted into the feeding tract, with the distal end of the feeding tube extending into the stomach and being retained therein by an internal anchor or bolster and the proximal end of the feeding tube extending through the abdominal wall.
  • gastrostomies were first performed surgically, most gastrostomies are now performed using percutaneous endoscopy and result in the implantation of a catheter/bolster assembly (also commonly referred to as a percutaneous endoscopic gastrostomy (PEG) device) in the patient.
  • PEG percutaneous endoscopic gastrostomy
  • an endoscope is intubated (i.e., inserted) into a patient's mouth and is passed through the esophagus into the stomach.
  • an entry site on the abdomen is identified using the endoscope for transillumination, and an incision is made by passing the distal end of a needle coupled to an outer cannula (e.g., an angiocath needle or a Seldinger needle) through the abdominal and stomach walls and into the stomach.
  • an outer cannula e.g., an angiocath needle or a Seldinger needle
  • the proximal end of the outer cannula remains outside of the body and acts as a stop to prevent the proximal end of the needle from falling into the stomach.
  • a snare is inserted into the stomach via the endoscope and is looped over the distal end of the needle. The snare is then "walked” up the needle until the outer cannula is snared. The snared cannula is then pulled proximally to tack the cannula to the stomach and, in turn, to secure the stomach wall to the abdominal wall. The needle is then removed while keeping the cannula in place.
  • a first end of a flexible guidewire is then passed through the cannula and into the stomach where it is grasped by the snare, the second end of the guidewire remaining external to the patient.
  • the endoscope and the snare are then withdrawn from the mouth of the patient to deliver the first end of the guidewire.
  • a push-type catheter implanting assembly is then inserted over the first end of the guidewire and is pushed overthe guidewire towards its second end.
  • the push- type catheter implanting assembly typically comprises a gastrostomy feeding tube, the gastrostomy feeding tube having a dome-shaped internal bolster disposed at its trailing end and having a tubular dilator serially connected to its leading end.
  • a "Y-port" adapter is typically attached to the proximal end of the implanted feeding tube, the Y-port adapter being adapted to receive a pair of connector tips through which food and/or medications may be dispensed.
  • a detachable locking clip is typically secured to the implanted feeding tube at a point between the external bolster and the Y-port adapter to prevent gastric fluids from escaping through the proximal end of the feeding tube when the feeding tube is not in use.
  • the pull method is similar in some respects to the above-described push method, the pull method differing from the push method in that, after the cannula is snared and the needle is removed therefrom, a first end of a suture is inserted through the cannula and into the stomach where it is grasped by the snare, the second end of the suture remaining external to the patient.
  • the endoscope and the snare are then withdrawn from the mouth of the patient to deliver the first end of the suture.
  • the first end of the suture is then coupled to the leading end of a pull-type catheter implanting assembly, the pull-type catheter implanting assembly typically comprising a gastrostomy feeding tube having an internal bolster at its trailing end and a plastic fitting at its leading end.
  • the plastic fitting typically has a barbed rear portion mounted within the leading end of the feeding tube and a conical front portion that serves as a dilator, said conical front portion tapering in diameter from the leading end of the feeding tube to a front tip.
  • a wire loop is fixed to the front tip of the plastic fitting, the first end of the suture being tied to the wire loop.
  • the pull-type catheter implanting assembly is then pulled retrograde through the patient until the gastrostomy feeding tube emerges from the abdomen of the patient and the internal bolster engages the stomach wall of the patient.
  • the clinician then re-intubates the patient with the endoscope in order to visually inspect the placement of the internal bolster within the stomach.
  • the implanted gastrostomy feeding tube is then typically cut to a desired length, an external bolster is typically secured to the cut implanted tube, a "Y- port" adapter is typically attached to the proximal end of the implanted feeding tube, and a detachable locking clip is typically secured to the implanted feeding tube at a point between the external bolster and the Y-port adapter.
  • the push and pull methods described above have achieved widespread use, particularly in the U.S., some people have expressed concern that the placement of a PEG device by the push method or the pull method may lead to infection of the stoma due to the fact that the PEG device is delivered to the stoma only after first being drawn through the patient's mouth, esophagus and stomach, all of which are unsterile environments populated by bacteria.
  • the push and pull methods described above require that an endoscope be introduced into the patient twice - first to deliver the snared guidewire or suture through the patient's mouth to the clinician and then again to permit a visual inspection of the placement of the internal bolster in the patient's stomach after the PEG device has been implanted.
  • such percutaneous approaches involve (i) inserting an endoscope into the patient and, through transillumination, identifying a desired insertion site; (ii) using sutures or T-fasteners, placed one at a time, to secure the abdominal wall to the stomach wall in a plurality of locations surrounding the future insertion site; (iii) using a scalpel to make an incision at the insertion site; (iv) using a series of dilators to enlarge the insertion site opening until said opening is large enough to pass therethrough the internal bolster at the distal end of a gastrostomy tube; and (v) sliding an external bolster over the proximal end of the gastrostomy tube down to skin level over the T-fastener wires or sutures.
  • the apparatus comprises a gastrostomy tube having an internal bolster which can be manipulated such that it has a reduced lateral extent; an axially-extending hollow sleeve which can surround the bolster to hold it in a position of reduced lateral extent; and a rip-cord capable of tearing the sheath.
  • the internal bolster is folded to have a smaller diameter, the sleeve is placed over the bolster and shrunk down to a smaller diameter.
  • the rip-cord runs distally along the outside of the tube, between the sleeve and the internal bolster, wraps over the distal end of the sleeve and runs proximally along the length of the tube.
  • the replacement tube can then be pushed through a stoma. Once in place, the rip cord is pulled to tear away the sleeve, thereby allowing the bolster to revert to its original lateral extent.
  • Other documents of interest include U.S. Published Patent Application No. US-
  • a medical catheter implanting assembly comprising (a) an outer sheath, said outer sheath having a proximal end and a distal end; (b) an inner sheath, said inner sheath having a proximal end and a distal end, said inner sheath being slidably mounted in said outer sheath; and (c) a medical catheter, said medical catheter having an internal bolster disposed at a distal end thereof, said medical catheter being inserted into said inner sheath, with said internal bolster being retained in a compressed state by said outer sheath; (d) whereby sliding movement of said outer sheath relative to said inner sheath release said internal bolster from said compressed state.
  • a medical catheter implanting assembly comprising (a) a dilator, said dilator having a proximal end and a distal end, said proximal end being shaped to define a cavity; (b) a stiffening sheath, said stiffening sheath having a proximal end and a distal end; and (c) a medical catheter, said medical catheter having an internal bolster disposed at a distal end thereof, said medical catheter being inserted into said stiffening sheath, with said internal bolster being retained in a compressed state in said cavity.
  • the present invention is also directed to a novel method for percutaneously implanting a medical catheter.
  • Fig. 1 is a perspective view of a first embodiment of a medical catheter implanting assembly constructed according to the teachings of the present invention, the medical catheter implanting assembly being shown in its retracted position
  • Fig.2 is a perspective view of the medical catheter implanting assembly shown in Fig. 1 , the medical catheter implanting assembly being shown in its advanced or deployed position
  • Fig. 3 is a fragmentary, partially exploded, perspective view of the medical catheter implanting assembly shown in Fig.
  • FIG. 6; Figs.9(a) through 9(i) are side views, partly in section, illustrating the operation of the medical catheter implanting assembly of Fig. 6;
  • FIG. 10 is a perspective view of a third embodiment of a medical catheter implanting assembly constructed according to the teachings of the present invention, the fasteners of the needle assemblies not being shown;
  • Fig. 11 is a partially exploded, perspective view of the medical catheter implanting assembly shown in Fig. 10;
  • Figs. 12(a) and 12(b) are proximal and distal views, respectively, of the bolster carrier shown in Fig. 10;
  • Fig. 13 is a proximal view of the external bolster shown in Fig. 10; Fig.
  • Fig. 14 is a side view of one of the needle sheaths shown in Fig. 10;
  • Fig. 15 is a perspective view, broken away in part, of the needle assembly shown in Fig. 10, the plunger of the needle assembly being shown in a retracted position;
  • Fig. 16 is a perspective view, broken away in part, of the feeding tube assembly shown in Fig. 10, said feeding tube assembly being shown with the internal bolster in a compressed state.
  • FIGs. 1 through 4 there are shown various view of a first embodiment of a medical catheter implanting assembly constructed according to the teachings of the present invention, said medical catheter implanting assembly being represented generally by reference numeral 11.
  • Assembly 11 includes a gastrostomy feeding tube 13, an internal bolster 14, an inner sheath 15, an inner sheath handle 17, an outer sheath 19 and an outer sheath handle 21.
  • Tube 13, which may be a conventional gastrostomy feeding tube, is an elongated, tubular member preferably made of a soft, biocompatible, silicone rubber. Tube 13 has a distal end 25 and a proximal end 27.
  • a series of ruler markings are printed on tube 13 and extend several inches from distal end 25 in the direction of proximal end 27 to facilitate the cutting of tube 13 to a desired length (after tube 13 has been implanted in a patient).
  • Internal bolster 14, which is also made of a soft, biocompatible, silicone rubber, is an enlarged, dome-shaped member securely disposed at distal end 25 of tube 13 for use in anchoring distal end 25 of tube 13 within a patient. In the present embodiment, bolster 14 forms a unitary structure with tube 13.
  • bolster 14 may be modified to come in a variety of different shapes and sizes and, if desired, may be replaced with a balloon-type bolster or other bolster that is transformable between an expanded anchoring state and a collapsed state.
  • Inner sheath 15, which is an elongated, unitary member, preferably made of a substantially rigid, biocompatible plastic (e.g., a high durometer polyethylene or polypropylene), includes a conical distal end 31 and a straight proximal end 33.
  • a short length of wire 34 is insert-molded into distal end 31 and extends distally therefrom.
  • a bore 35 extends longitudinally from proximal end 33 in the direction of distal end 31 , bore 35 terminating a short distance before distal end 31. For reasons to become apparent below, bore 35 is appropriately dimensioned to slidably receive gastrostomy feeding tube 13.
  • a transverse window 37 having a scalloped shape is provided in inner sheath 15, window 37 communicating with bore 35 at its distal end.
  • Inner sheath handle 17, which is an elongated, tubular, unitary member, preferably made of a rigid plastic, includes a distal end 41 and a proximal end 43. Distal end 41 of handle 17 is inserted over proximal end 33 of inner sheath 15 and is securely fixed thereto.
  • Proximal end 43 of handle 17 is shaped to include an annular embossment 45 which facilitates the gripping of handle 17 by a user and, as will become apparent below, acts as a stop to limit distal movement of inner sheath 15, embossment 45 being shaped to include three larger diameter rings 45-1 through 45-3 separated by two smaller diameter rings 45-4 and 45-5.
  • a longitudinal bore 55 extends from distal end 51 to proximal end 53, bore 55 being appropriately dimensioned to slidably receive inner sheath 17.
  • Outer sheath handle 21 which is an elongated, tubular, unitary member, preferably made of a rigid plastic, includes a distal end 61 and a proximal end 63. Distal end 61 of handle 21 is inserted over proximal end 53 of outer sheath 19 and is securely fixed thereto.
  • a plurality of annular embossments 65-1 , 65-2 and 66 are formed on the outer surface of handle 21 to facilitate the gripping of handle 21 by a user.
  • proximal end 27 of tube 13 is inserted through window 37 and into bore 35 of inner sheath 15.
  • the remainder of tube 13 is then fed through window 37 and into bore 35 until proximal end 27 of tube 13 emerges from handle 17 and bolster 14 is positioned just outside of window 37.
  • Bolster 14 is then compressed and tucked tightly into window 37 as tube 13 is tensioned proximally and distal end 51 of outer sheath 19 is moved distally over window 37, sheath 19 serving to retain bolster 14 in window 37.
  • an endoscope E is inserted into the stomach of the patient and is used to transilluminate an incision site.
  • An incision is then made by passing the distal end of a needle N coupled to a peelable cannula C through the abdominal wall A and the stomach wall S and into the stomach (see Fig. 5(a)).
  • a snare L is inserted into the stomach via endoscope E and is looped overthe distal end of needle N (see Fig. 5(b)). Snare L is then "walked” up needle N until peelable cannula C is snared.
  • the snared cannula C is then pulled to tack cannula C to abdominal wall A and, in turn, to tack abdominal wall A to stomach wall S. Needle N is then removed while keeping peelable cannula C in place (see Fig. 5(c)).
  • One to four T-fasteners F are then used to provide further securing of abdominal wall A to stomach wall S (see Fig. 5(d)).
  • the distal end of assembly 11 is inserted through peelable cannula C and into the stomach, and snare L is moved from peelable cannula C to wire 34 (see Fig. 5(e)).
  • Peelable cannula C is then peeled in half and removed laterally in two pieces from the incision site, and assembly 11 is inserted further into the stomach (both by pushing assembly 11 from outside the patient and by using snare L to pull assembly 11 from inside the patient) until distal end 51 of outer sheath 19 can be seen by endoscope E (see Fig. 5(f)). Then, using handle 21 to keep outer sheath 19 stationary, handle 17 is used to move inner sheath 15 distally relative to outer sheath 19 until window 37 is advanced beyond distal end 51 of outer sheath 19.
  • bolster 14 With window 37 no longer covered by outer sheath 19, bolster 14 immediately springs back to its decompressed shape, which is larger than window 37; as a result, bolster 14 exits window 37 (see Fig. 5(g)). Snare L is then removed from wire 34 and retracted into endoscope E, and inner sheath 15 and outer sheath 19 are removed from the patient, allowing bolster 14 to engage the stomach wall S (see Fig. 5(h)). Endoscope E is then used to image the placement of bolster 14. Assuming that bolster 14 is placed properly, endoscope E is then removed from the patient.
  • assembly 11 one benefit to using assembly 11 is that the gastrostomy feeding tube is not fed through the mouth, esophagus and stomach of the patient and, therefore, does not suffer from the possible complications resulting from microbial contamination of the feeding tube. Another benefit is that the endoscope does not need to be intubated into the patient twice, but rather, may be inserted into the patient and then remain in the patient throughout the implantation and inspection processes.
  • assembly 11 has been described herein in the context of gastrostomy feeding, assembly 11 is not limited to gastrostomy feeding and may be used for other types of feeding, as well as for drainage.
  • bolster 14 has been described herein as a self-expandable, mushroom-shaped or dome-shaped bolster, bolster 14 could be replaced with a conventional balloon-type bolster or a bolster having a malecot structure.
  • Assembly 111 includes a gastrostomy feeding tube 113, an internal bolster 114, a dilator 115, a stiffening sheath 117, a length of shrink tubing 119 and a cap 121.
  • Gastrostomy feeding tube 113 and internal bolster 114 may be identical to gastrostomy feeding tube 13 and bolster 14, respectively, of assembly 11.
  • Dilator 115 which is an elongated, generally conical, unitary member, preferably made of a substantially rigid, biocompatible plastic (e.g., a high durometer polyethylene or polypropylene), includes a distal end 131 and a proximal end 133.
  • a short length of wire 134 is insert- molded into distal end 131 and extends distally therefrom.
  • a small cavity 135 is centrally provided in proximal end 133 and extends a short distance distally, cavity 135 being surrounded by a plurality of flexible fingers 137.
  • Stiffening sheath 117 which is an elongated, tubular, unitary member, preferably made of a rigid, biocompatible plastic, has a distal end 141 , a proximal end 143 and a longitudinal bore 145.
  • Sheath 117 which is inserted over tube 113 to provide column strength to tube 113, has a length such that bolster 114 extends just beyond distal end 141 of sheath 117 and such that a proximal end 127 of tube 113 extends just beyond proximal end 143 of sheath 117.
  • such perforations 157 do not continue proximally all the way to proximal end 153 since it is desirable for shrink tubing 119 to remain tightly fixed to sheath 117 in order that tubing 119 may be removed from the patient with sheath 117.
  • a marking 159 is preferably circumferentially provided on the outer surface of tubing 119, marking 159 denoting the location of internal bolster 114 within dilator 115.
  • Cap 121 which is a unitary member, preferably made of a rigid, biocompatible plastic, is shaped to include a circular top wall 161 , a circular side wall 163 and a centrally disposed circular plug 165.
  • cap 121 also serves to prevent matter from entering tube 113 prior to the implanting of tube 113 in a patient.
  • tube 113 is inserted into sheath 117 so that bolster 114 extends distally beyond sheath 117 and so that proximal end 127 of tube remains proximal to sheath 117.
  • the proximal end 127 of tube 113 is then secured to sheath 117 using cap 121.
  • Bolster 114 is then compressed and inserted into cavity 125 of dilator 115.
  • Figs. 9(a) through 9(i) the manner in which assembly 111 may be used to percutaneously implant tube 113 in a patient is illustrated.
  • an endoscope E is inserted into the stomach of the patient and is used to transilluminate an incision site.
  • An incision is then made by passing the distal end of a needle N coupled to a peelable cannula C through the abdominal wall A and the stomach wall S and into the stomach (see Fig. 9(a)).
  • a snare L is inserted into the stomach via endoscope E and is looped overthe distal end of needle N (see Fig. 9(b)).
  • Snare L is then "walked” up needle N until peelable cannula C is snared.
  • the snared cannula C is then pulled to tack cannula C to abdominal wall A and, in turn, to tack abdominal wall A to stomach wall S. Needle N is then removed while keeping peelable cannula C in place (see Fig. 9(c)).
  • One to four T-fasteners F are then used to provide further securing of abdominal wall A to stomach wall S (see Fig. 9(d)).
  • wire 134 is inserted through peelable cannula C and into the stomach, and snare L is moved from peelable cannula C to wire 134 (see Fig. 9(e)).
  • Peelable cannula C is then peeled in half and removed laterally in two pieces from the incision site, and assembly 111 is inserted further into the stomach (both by pushing assembly 111 from outside the patient and by using snare L to pull assembly 111 from inside the patient) until marking 159 can be seen by endoscope E (see Fig.9(f)).
  • snare L is used to completely remove dilator 115 from bolster 114, thereby allowing bolster 114 to engage the stomach wall S (see Fig. 9(h)).
  • cap 121 is removed from proximal end 127 of tube 113 to decouple tube 113 from sheath 117, and sheath 117 and tubing 119 are then slid proximally off tube 113.
  • Endoscope E is then used to image the placement of bolster 114 (see Fig. 9(i)).
  • dilator 115 of the present embodiment is shown having a certain length, dilator 115 could be modified to have a comparatively smaller length.
  • one alternative dilator is a solid, short member that does not include a finger-surrounded cavity into which the bolster fits. Instead, the dilator proximally terminates at a flat, solid end with a protruding rod, the bolster being compressed centrally around this protruding rod.
  • dilator 115 differs from dilator 115 in that fingers 137 are replaced with a solid wall.
  • the cavity in which the bolster is received may be treated with a lubricious coating which allows the bolster to exit the cavity with little friction upon launch.
  • dilator 115 could be made of a biodegradable material and/or that wire 134 could be replaced with a loop of the type used in a pull-type catheter implanting assembly.
  • assembly 111 has been described herein in the context of gastrostomy feeding, assembly 111 is not limited to gastrostomy feeding and may be used for other types of feeding, as well as for drainage.
  • fasteners are also typically used to fasten the abdominal and stomach walls to one another prior to the use of a scalpel to make the incision. Examples of such fasteners are disclosed in U.S. Patent Nos. 5,341 ,823 and 4,705,040, both of which are incorporated herein by reference. Typically, such fasteners are independently placed at locations surrounding the future incision site. Referring now to Figs.
  • Bolster carrier 231 is a generally triangular, unitary member, preferably made of a rigid metal or plastic, and having an annular embossment 233 extending proximally a short distance from its proximal surface 235. Embossment 233 is inserted into the distal end of bore 223 and is secured therewithin. For reasons to become apparent below, embossment 233 is hollow and has an open distal end 237. Assembly 211 also comprises an external bolster 241 (also shown separately in Fig. 13), external bolster 241 being a generally triangular, unitary member, preferably made of silicone or a similarly flexible, biocompatible material.
  • Bolster 241 has an outer perimeter dimensioned to approximate the outer perimeter of bolster carrier 231.
  • Bolster 241 is shaped to include an annular embossment 243 extending proximally a short distance from its proximal surface 245, embossment 243 being received in the hollow walls of embossment 233 of carrier bolster 231 through its open distal end 237.
  • Bolster 241 is also shaped to include a plurality of transverse openings 246-1 through 246-3, the purpose of which will be described below.
  • Assembly 211 further comprises a plurality of identical needle sheaths 251 -1 , 251-2 and 251-3 (needle sheath 251-1 also being shown separately in Fig. 14).
  • Needle sheaths 251-1 through 251-3 are slotted, tubular members having proximal ends 253-1 through 253-3, respectively, and distal ends 255-1 through 255-3, respectively.
  • Proximal ends 253-1 through 253-3 are fixedly mounted within sleeves 257-1 through 257-3 (sleeve 257-3 not being visible as shown), respectively, formed on proximal portion 219 of barrel portion 217.
  • Distal ends 255-1 through 255-3 are fixedly mounted within slotted openings 259-1 through 259-3 located near the vertices of bolster carrier 231.
  • Assembly 211 further comprises a plurality of identical needle assemblies 261 - 1 through 261-3. Needle assemblies 261-1 through 261-3, which may be of the type disclosed in U.S. Patent Nos.
  • Assembly 261-1 also includes a plunger 267, plunger 267 being slidably mounted within bore 264.
  • Assembly 261-1 additionally includes a short length of tubing 269 slidably disposed within bore 265 and adapted to be ejected from the distal end of bore 265 by distal movement of plunger 267 relative to needle 263.
  • Assembly 261-1 further includes a suture 271 coupled at one end to the approximate midpoint of tubing 269.
  • assembly 211 further includes a trocar 281 , trocar 281 being made of a rigid metal and having a sharp distal end 283 and an enlarged proximal end 285.
  • Trocar 281 is appropriately dimensioned to be slidably and removably mounted in bore 223 of casing 213, with distal end 283 of trocar 281 being positionable past bolster carrier 231 and external bolster 241 to form an incision in a patient.
  • Assembly 211 further includes a feeding tube assembly 291 (which is also shown separately in Fig. 16), assembly 291 comprising a feeding tube 293 having an internal bolster 294 at its distal end, an inner sheath 295 and an outer sheath 296.
  • Feeding tube 293 and internal bolster 294 may be identical to feeding tube 13 and bolster 14, respectively, of assembly 11.
  • Inner sheath 295 is a unitary, tubular member having a proximal end 297 and a distal end 299.
  • Proximal end 305 of outer sheath 296 is inserted into and secured within a tubular handle 309.
  • outer sheath 296 is appropriately dimensioned to receive bolster 294 in a compressed state and to permit inner sheath 295 to slide relative to outer sheath 296.
  • Bolster 294, distal end 299 of inner sheath 295 and distal end 293-2 of tube 293 are all positioned within outer sheath 296.
  • To launch tube 293 and bolster 294 using assembly 291 one slides inner sheath 295 distally relative to outer sheath 296 until inner sheath 295 advances bolster 294 beyond distal end 307 of outer sheath 296, thereby allowing bolster 294 to decompress to its relaxed state.
  • Inner sheath 295 and outer sheath 296 are then withdrawn proximally relative to bolster 294.
  • assembly 211 to fasten together the abdominal and stomach walls of a patient, one positions casing 213 (with bore 223 preferably temporarily unoccupied by either trocar 281 or assembly 291 ) so that external bolster 241 is placed against the abdominal wall of a patient and centered around a desired incision site.
  • plungers 267 are moved distally to eject tubes 269-1 through 269-3 from needles 263-1 through 263-3, respectively.
  • Needles 263-1 through 263-3 are then withdrawn proximally from the patient and may additionally be proximally withdrawn from sheaths 251-1 through 251-3 to avoid accidental needle sticks.
  • sutures 271-1 through 271-3 are pulled taut and then crimped, knotted, or the like to tack together the abdominal and stomach walls. Because sutures 271 -1 through 271 -3 extend through openings 246- 1 through 246-3, respectively of bolster 241 , bolster 241 becomes coupled in this manner to the patient.
  • needle assemblies 261 -1 through 261 -3 have been described above as being operated simultaneously, they are preferably advanced serially to minimize the possibility of needles 263-1 through 263-3 pushing away the stomach.
  • one benefit to using assembly 211 in the above-described manner to fasten together the abdominal and stomach walls is that the spacing and relative positions of the fasteners may be controlled according to a predetermined design.
  • trocar 281 may be used to form incisions in the abdominal and stomach walls, respectively, of the patient. This may be done by inserting distal end 283 of trocar 281 into bore 223 and advancing trocar 281 distally until proximal end 285 of trocar 281 abuts casing 213, at which time distal end 283 will have extended distally beyond bolster 241 and entered the patient.
  • Trocar 281 may then be removed from bore 223, and assembly 291 may be inserted into bore 223. Assembly 291 may then be used to launch tube 293 and bolster 294 in the manner discussed above. It should be noted that, instead of using a feeding tube having a self- expandable, mushroom-shaped or dome-shaped bolster like bolster 294, one could use a feeding tube having an inflatable balloon-type bolster or any other bolster that is transformable between an expanded anchoring state and a collapsed state. It should also be noted that, although assembly 211 has been described herein in the context of gastrostomy feeding, assembly 211 is not limited to gastrostomy feeding and may be used for other types of feeding, as well as for drainage.

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Abstract

Méthode pour l’implantation par voie percutanée d’un cathéter médical, tel qu’une sonde d’alimentation par gastrostomie, et assemblage de l’implantation d’un cathéter médical. Dans un mode de réalisation, l’assemblage de l’implantation comprend une sonde d’alimentation par gastrostomie, une gaine intérieure et une gaine extérieure. La sonde d’alimentation possède un boudin interne intégralement formé à son extrémité distale. La gaine intérieure comprend une canule qui s’étend de façon distale de son extrémité proximale à un point précédent son extrémité distale, et une fenêtre transversale qui communique avec la canule. La gaine extérieure comprend une extrémité proximale, une extrémité distale et une canule longitudinale. La gaine extérieure est insérée par-dessus la gaine intérieure, et la sonde d’alimentation est insérée dans la gaine intérieure, tandis que le boudin interne est plié et enchâssé dans la fenêtre, où il est retenu par la gaine extérieure. Le mouvement de la gaine extérieure par rapport à la gaine intérieure en exposant la fenêtre permet au boudin de décompresser.
PCT/US2005/017496 2004-05-14 2005-05-14 Méthode pour l’implantation d’un cathéter médical par voie percutanée et assemblage de l’implantation d’un cathéter médical Ceased WO2005112801A2 (fr)

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EP05750796A EP1758510A2 (fr) 2004-05-14 2005-05-14 Méthode pour l'implantation d'un cathéter médical par voie percutanée et assemblage de l'implantation d'un cathéter médical
JP2007513486A JP4805257B2 (ja) 2004-05-14 2005-05-14 医療用カテーテル埋め込みアセンブリ

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US10/846,833 2004-05-14
US10/846,833 US7654980B2 (en) 2004-05-14 2004-05-14 Method for percutaneously implanting a medical catheter and medical catheter implanting assembly

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WO2005112801A2 true WO2005112801A2 (fr) 2005-12-01
WO2005112801A3 WO2005112801A3 (fr) 2006-04-13

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JP2008054739A (ja) * 2006-08-29 2008-03-13 Kazuo Hanagasaki 胃ろうカテーテル導入装置
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JP2008054739A (ja) * 2006-08-29 2008-03-13 Kazuo Hanagasaki 胃ろうカテーテル導入装置
US7766876B2 (en) 2006-08-29 2010-08-03 Kazuo Hanagasaki Gastrostomy catheter introducing device
WO2010088374A1 (fr) * 2009-01-29 2010-08-05 Boston Scientific Scimed, Inc. Emploi d'une gaine secondaire avec un cathéter d'ablation
US8821485B2 (en) 2009-01-29 2014-09-02 Boston Scientific Scimed, Inc. Employing a secondary sheath with an ablation catheter
EP2441488A1 (fr) * 2010-10-15 2012-04-18 Iyunni Venkata Sesha Sayi Nath Cathéter avec un dilatateur détachable
EP3037123A1 (fr) * 2010-10-15 2016-06-29 Iyunni Venkata Sesha Sayi Nath Système de cathéter à ballonnet et procédé d'assemblage dudit système

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Publication number Publication date
EP1758510A2 (fr) 2007-03-07
US8439869B2 (en) 2013-05-14
US8043261B2 (en) 2011-10-25
US20120010570A1 (en) 2012-01-12
US20100094212A1 (en) 2010-04-15
JP4805257B2 (ja) 2011-11-02
JP2007537795A (ja) 2007-12-27
US20050256455A1 (en) 2005-11-17
US7654980B2 (en) 2010-02-02
WO2005112801A3 (fr) 2006-04-13

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